An interventional study of Closed-loop DBS stimulation for 24 hours and Open-loop DBS stimulation for 24 hours in Parkinson Disease, sponsored by Tsinghua University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Tsinghua University · Not applicable, Interventional, and Treatment
Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Tsinghua University is the lead sponsor of 24 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be implanted with bilateral STN DBS using PINS 106RS system. DBS stimulation will be initiated one month post surgery. Follow-up visits will be conducted 1/3/6/9/12/15 months post surgery with clinical evaluation, STN LFP recording and resting state functional MRI testing. During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop DBS therapy.
Other: Closed-loop DBS stimulation for 24 hours · Other: Open-loop DBS stimulation for 24 hours · Other: Closed-loop DBS stimulation for 72 hours · Other: Open-loop DBS stimulation for 72 hours
Continuous closed-loop modulation for 24 hours
Continuous open-loop modulation for 24 hours
Continuous closed-loop modulation for 72 hours
Continuous open-loop modulation for 72 hours
Movement disorders evaluation
Using MDS-UPDRS III rating scale （0-132, the higher score means a worse outcome） and Rush dyskinesia rating scale （0-12, the higher score means a worse outcome） combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition
Time frame: 1-3 days
Sleep Structure Evaluation
Using polysomnography evaluation （sleep efficiency，N1/N2/N3/REM/Wake after sleep onset duration and percentage，arousal index） and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition
Time frame: 1-3 nights
Diary Outcomes in Parkinson's Disease
Using SCOPA-DC （0-87, the higher score means a worse outcome） to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition
Time frame: 1-3days
Safety (Stimulation-related AEs) and Subjective Satisfactory
Number of modulation related Adverse Events or abnormal vital signs.
Time frame: 1-3days
Total Electrical Energy Delivered to patients
To evaluate the energy changes in closed-loop DBS and open-loop DBS modualtion
Time frame: 1-3days
Neurophysiological changes of STN-LFP in daytime and sleep
Changes of the power and entropy features of delta, theta, alpha, beta and gamma oscillations
Time frame: at 3,6,9,12,15 months compared to baseline
Functional connectivity changes during long-term DBS modulation
Changes of subcortical and cortical functional connectivity
Time frame: at 3,6,9,12,15 months compared to baseline
Plan to share: No
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